Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Description

The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are: Primary Hypothesis 1: Peristomal Skin Complications will decrease Primary Hypothesis 2: Dressing Leak Rates will decrease Participants will: * Receive either the Limpet device or standard of care adhesive ostomy pouch dressing * Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Conditions

Ostomy, Enterocutaneous Fistula

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to evaluate the safety and effectiveness of the Limpet, as compared to standard of care ostomy pouches, in reducing complications for ostomy and fistula patients. Secondary objectives include evaluating dressing leak rates and causes of complications (e.g., edema, tissue oxygen saturation, and poor stoma eversion). The main questions it aims to answer are: Primary Hypothesis 1: Peristomal Skin Complications will decrease Primary Hypothesis 2: Dressing Leak Rates will decrease Participants will: * Receive either the Limpet device or standard of care adhesive ostomy pouch dressing * Return every 7 days for study visits for 30 days to receive device replacement, wound imaging, blood tests, and quality of life surveys.

Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Novel Post-Surgical Incision Management to Prevent Ostomy Complications

Condition
Ostomy
Intervention / Treatment

-

Contacts and Locations

Saint Paul

Regions Hospital, Saint Paul, Minnesota, United States, 55101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant is greater than 18 years of age, inclusive
  • * Participant is undergoing ileostomy surgery or,
  • * has an enterocutaneous fistula with output over 500cc in 24 hours
  • * Participants stoma will have a maximum diameter of 1.5 inches based on measurements from the Investigator or Sponsor.
  • * Area around the stoma must have no injury through the dermis (i.e., intact skin)
  • * Participant is willing and able to comply with all protocol-specified requirements
  • * Participant is capable of reading and understanding English, Spanish, Hmong, or Somali; and will provide written informed consent to participate.
  • * Nicotine use in the 7 days prior to application
  • * Unable/unwilling to attend the follow-up appointments
  • * Participant has a life expectancy \< 30 days.
  • * Participant has a stature too small for use of the Limpet in the opinion of the Investigator or Sponsor.
  • * Participant has an enteroatmospheric fistula (enteric fistula to an open wound)
  • * Participant is scheduling/planning concurrent chemotherapy or other radiation treatment during the study follow-up period
  • * Participant has a history of sensitivity or allergy to hydrocolloids or other materials in the Limpet device.
  • * Participant is pregnant or planning to become pregnant (verbal report).
  • * Participant is unable or unwilling to provide informed consent.
  • * Participant is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
  • * Participant has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.
  • * Participant is present on the Research Exclusion list

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

HealthPartners Institute,

Study Record Dates

2025-09